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United States · US · US:81864-103_0439799e-24bf-4208-bc66-a04aa9ce9533
Ojjaara
Orange BookUNIISPLATC L01EJ04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlaxoSmithKline LLC
CountryUS (United States)
ATC codeL01EJ04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11818641033030 TABLET in 1 BOTTLE (81864-103-30)
Annotations
UNII (FDA Substance ID)
LDX8893L5D
MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
Orange Book
N216873
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "LDX8893L5D",
"rxcui": null,
"inchikey": "RQKCPSIFARJBOR-UHFFFAOYSA-N",
"display_name": "MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4a672fd1-eb7b-4aa9-9b23-845e4b5dc400": {
"match": "brand_token",
"title": "OJJAARA (MOMELOTINIB) TABLET [GLAXOSMITHKLINE LLC]",
"spl_version": "8",
"published_date": "2026-05-21"
}
},
"productid": "81864-103_0439799e-24bf-4208-bc66-a04aa9ce9533",
"productndc": "81864-103",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216873",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "001",
"approval_date": "Sep 15, 2023"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Sep 15, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG BASE",
"product_no": "003",
"approval_date": "Sep 15, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE",
"proprietary_name": "Ojjaara",
"active_ingred_unit": "mg/1",
"application_number": "NDA216873",
"marketing_category": "NDA",
"nonproprietary_name": "Momelotinib",
"start_marketing_date": "20230915",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01EJ04.
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